Evidence map›Paper›PMID 40491461›Full record

ArticleERJ open research2025

AeroVax: study protocol for a randomised, double-blind, placebo-controlled, phase 2 trial to evaluate safety and immunogenicity of a next-generation COVID-19 vaccine delivered by inhaled aerosol to humans.

Adam S Komorowski, Lawrence Mbuagbaw, Mangalakumari Jeyanathan, Sam Afkhami, Marilyn Swinton, Michael R D'Agostino, Karen Howie, Maria Fe C Medina, Gail M Gauvreau, Danica L Brister and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ERJ open research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Adam S KomorowskiDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0003-2101-7701
Lawrence MbuagbawDepartment of Health Research Methodology, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0001-5855-5461
Mangalakumari JeyanathanMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Sam AfkhamiMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Marilyn SwintonDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Michael R D'AgostinoMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0001-6781-9692
Karen HowieDivision of Respirology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Maria Fe C MedinaMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Gail M GauvreauDivision of Respirology, Department of Medicine, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-6187-2385
Danica L BristerDivision of Respirology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Imran SatiaDepartment of Health Research Methodology, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0003-4206-6000
Brian D LichtyMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Matthew S MillerMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Donald W CameronDivisions of Infectious Diseases and Respirology, University of Ottawa at the Ottawa Hospital, Ottawa, ON, Canada.
Scott HalperinCanadian Center for Vaccinology, Departments of Pediatrics and Microbiology and Immunology, Dalhousie University, Halifax, ON, Canada.
Lehana ThabaneDepartment of Health Research Methodology, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Mark LoebDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Zhou XingMichael G. DeGroote Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada.
Fiona M SmaillDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to have a significant impact worldwide, in part due to a reduction in neutralising antibody protection provided by vaccines targeting monovalent spike antigens related to immune escape. Development of vaccines amenable for respiratory mucosal delivery that provide broad and durable immunity are needed. This study aims to determine the safety and immunogenicity of a single inhaled dose of a replication-deficient chimpanzee adenovirus type 68 vector expressing a trivalent transgene cassette of SARS-CoV-2 S1 domain of spike, nucleocapsid and RNA polymerase genes (ChAd-triCoV/Mac). Methods: We plan to recruit 350 nonpregnant adults aged 18-65 who have previously received three intramuscular SARS-CoV-2 mRNA vaccines in this 24-week, multicentre, double-blind, parallel-group, phase II, two-sided superiority randomised controlled trial. Participants will be randomised 2:1 to receive either a single inhaled dose of ChAd-triCoV/Mac or placebo, both aerosolised Conclusion: This placebo-controlled phase 2 randomised trial will test the safety and immunogenicity of an inhaled, nebulised ChAd-triCoV/Mac SARS-CoV-2 vaccine that is novel in its administration route and targeting of multiple viral epitopes. The results will provide further information regarding the mucosal T-cell response to immunisation.

Identifiers

PMID40491461
PMCPMC12147143

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.